Content of review 1, reviewed on June 02, 2023

The paper describes a post-hoc subgroup analysis of data from two outcomes trials of finerenone combined (FIDELIO-DKD and FIGARO-DKD).

The objective was to asses if finerenone affects the liver impairment status in patients with elevated markers of liver steatosis, elevated transaminases, and high fibrosis scores, and if liver function impairment affects the renal and CV outcomes benefits demonstrated in the overall patient population in the original studies.

The analysis showed a neutral effect of finerenone on liver function; and maintained renal and CV benefit irrespective of the liver impairment status. Also, the CV benefit appears to be higher with higher degrees of fibrosis (assessed by Fib-4 score).

The questions addressed in the paper as well as the results are clinically interesting; and the paper is well-written.

Also, the analysis generates interesting hypotheses for future research, e.g. the potential benefits of finerenone in patients with high liver fibrosis scores but without CKD or T2D.

While the limitations of the analysis are well described at the end of the discussion section, it is important that the post-hoc nature of the analysis, the specific population studies and the exclusion of patients with severe hepatic clearly pointed out in the conclusions, including the abstract.

Source

    © 2023 the Reviewer.

References

    Nikolaos, P., R., B. S., L., B. A., Andreas, L., Muenevver, D., D., A. S., Gerasimos, F., Bertram, P., Peter, R., M., R. L., Peter, K., Robert, L., Charlie, S., L., B. G. 2024. Efficacy of finerenone in patients with type 2 diabetes, chronic kidney disease and altered markers of liver steatosis and fibrosis: A FIDELITY subgroup analysis. Diabetes, Obesity and Metabolism.